Stabilizing Myopia by Accelerating Reshaping Technique (SMART)-Study Three Year Outcomes and Overview

Objectives: The SMART study is a three-year, longitudinal, multicenter evaluation comparing corneal reshaping contact lenses (CRCL) influence on the progression of myopia in children (age 8 to 14 at enrollment) to the wearing of soft silicone hydrogel contact lenses (SCL) worn on a daily wear basis with monthly replacement. This study represents one of the largest patient enrollment with ten investigators and adds to the literature by verifying the outcomes of smaller enrolled investigations strengthen the outcomes of corneal reshaping techniques. Methods: At enrollment 172 subjects were fit with corneal reshaping contact lenses worn overnight on a nightly basis (Emerald design by Euclid Systems) and 110 subjects were fit with silicone hydrogel contact lenses on a daily wear monthly-replacement basis (Pure Vision by Bausch & Lomb). Visits were conducted at 24 hours, one week, one month, three months, and every six months thereafter for three years. A regression protocol was conducted for the CRCL subjects at each yearly visit for three years by discontinuing lens wear and monitoring for stability of refraction and topography for consecutive visits until baseline was reached. Results: The outcome of the three-year investigation indicated that myopia progressed at a statistically significantly higher degree in the SCL group as compared to the CRCL group. Mean spherical equivalent change in myopia for the SCL group was -1.03 ± 0.58 diopters, vs. CRCL group -0.13 ± 0.62 diopters s (p < 0.0001). There were no cases of reduced best corrected visual acuity for three years for either group. There were no significant adverse events in either group from baseline to the three-years. 80% of eyes were successfully fit with CRCL with the first lens fit empirically and 95% of eyes were fit successfully with only one lens change. There was no significant difference between dropout rates during the three year study between the two groups. Conclusion: The three year longitudinal study found that myopia progressed at a significantly higher degree in the SCL vs. CRCL subjects. . Efficacy, safety, and dropout rate of corneal reshaping in our sample population appears to be comparable to wearing SCL.